FDA.reportPublic FDA data

Balsamicum

Manufacturer
Uriel Pharmacy, Inc
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:30:15

Label at a glance#

ProductBalsamicum
Active ingredientBALSAM PERU, LARIX DECIDUA RESIN, MERCURIALIS PERENNIS, CALENDULA OFFICINALIS FLOWERING TOP, ANTIMONY
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Apply to skin as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Calendula essence 1X, Mercurialis essence (Dog’s mercury) 1X, Resina laricis (Larch resin) 1X, Stibium (Antimony) 1X, Peruvian balsam 1x

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic Olive oil, Lanolin, Sunflower seed oil, Yellow beeswax, Spring water, Organic cane alcohol, Sorbic acid, Tea tree oil, Grapefruit seed extract

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Uses: Temporary relief of minor wounds.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Balsamicum OintmentBalsamicum Ointment

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-2159-2Balsamicum30 g in 1 TUBEOINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-2159BALSAMICUM OINTMENT [URIEL PHARMACY, INC]1Current NDC, 1 package rows20250112_2b6073f5-238f-eff8-e063-6294a90a581a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-215948951-2159-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BALSAM PERU8P5F881OCYACTIB
SORBIC ACIDX045WJ989BIACT
LARIX DECIDUA RESINAD8LJ73GQFACTIB
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
WATER059QF0KO0RIACT
LANOLIN7EV65EAW6HIACT
MERCURIALIS PERENNISQ35465A1MAACTIB
BEESWAX2ZA36H0S2VIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ALCOHOL3K9958V90MIACT
TEA TREE OILVIF565UC2GIACT
ANTIMONY9IT35J3UV3ACTIB
CITRUS PARADISI SEED12F08874Y7IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BalsamicumBALSAMICUMUriel Pharmacy, Inc2b6073f5-238f-eff8-e063-6294a90a581a2025-01-10WarningsExact identifier
ndc (package): 48951-2159-2
ndc (product): 48951-2159
ndc11 (package): 48951215902
spl id: 2b6073f5-2390-eff8-e063-6294a90a581a
spl set id: 2b6073f5-238f-eff8-e063-6294a90a581a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.